Announcement Type
This is a reissue of PAR-05-026,
which was previously released December 2, 2004.

NOTICE: Applications submitted in response to this Funding Opportunity
Announcement (FOA) for Federal assistance must be submitted electronically
through Grants.gov (http://www.grants.gov)
using the SF424 Research and Related (R&R) forms and the SF424 (R&R)
Application Guide.

APPLICATIONS MAY NOT
BE SUBMITTED IN PAPER FORMAT.

This FOA must be read
in conjunction with the application guidelines included with this announcement
in Grants.gov/Apply
for Grants (hereafter called Grants.gov/Apply).

A registration process
is necessary before submission and applicants are highly encouraged to start
the process at least four weeks prior to the grant submission date. See Section IV.

Key Dates
Release/Posted
Date: January 8, 2007
Opening Date: January 8, 2007 (Earliest date an
application may be submitted to Grants.gov) Letters of Intent Receipt Date(s): April
17, 2007 NOTE: On time submission requires that applications
be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of
the applicant institution/organization). ApplicationSubmission/Receipt Date(s): May 17, 2007Peer Review Date(s): October-November,
2007 Council Review Date(s): January-February, 2008Earliest Anticipated Start
Date(s): April 2008Additional Information To Be
Available Date (Activation Date):Not ApplicableExpiration
Date: May 18, 2007

Due Dates for E.O. 12372

Not Applicable

Additional
Overview Content

Executive Summary

Purpose. The ultimate goal of this Funding
Opportunity Announcement (FOA) is to support research on health promotion,
disease prevention, and health disparities that is jointly conducted by
communities and researchers.

Mechanism of Support. This
FOA will utilize the NIH research project grant (R01) award mechanism and runs
in parallel with an FOA of identical scientific scope, PAR-06-247, that
solicits applications under the Exploratory/Developmental
Grant (R21) award mechanism.

Funds Available and Anticipated Number of Awards.Because
the nature and scope of the proposed research will vary from application to
application, it is anticipated that the size and duration
of each award will also vary. The total amount awarded and the number of awards
will depend upon the mechanism numbers, quality, duration, and costs of the
applications received

Eligible
Project Directors/Principal Investigators (PDs/PIs).Individuals with the skills, knowledge, and resources
necessary to carry out the proposed research are invited to work with their institution/organization
to develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Number
of Applications. Applicants may submit more than one application,
provided each application is scientifically distinct.

Renewals and Resubmissions.At this time,
it is not known if competing renewal (formerly “competing continuation”)
applications will be accepted and/or if this FOA will be reissued. Applicants
may submit a “resubmission” application, but such application must include
an “Introduction” addressing the previous peer review critique (Summary
Statement).

Number of PDs/PIs. More than one PD/PI, or
multiple PDs/PIs, may be designated on the application.

This Funding Opportunity Announcement (FOA)
solicits grant applications that propose research on health promotion, disease
prevention, and health disparities that is jointly conducted by communities and
researchers.

Community-based
participatory research (CBPR) is defined as scientific inquiry conducted in
communities and in partnership with researchers. The process of scientific
inquiry is such that community members, persons affected by the health
condition, disability or issue under study, or other key stakeholders in the
community's health have the opportunity to be full participants in each phase
of the work (from conception - design - conduct - analysis - interpretation -
conclusions - communication of results). CBPR is characterized by substantial
community input in the development of the grant application (http://www.niehs.nih.gov/translat/cbpr/cbpr.htm).

Community-partnered
approaches to research promise to deepen our scientific base of knowledge in
the areas of health promotion, disease prevention, and health disparities.
Community-partnered research processes offer the potential to generate
better-informed hypotheses, develop more effective interventions, and enhance
the translation of the research results into practice. Specifically, involving
community and academic partners as research collaborators may improve the
quality and impact of research by:

More effectively focusing the
research questions on health issues of greatest relevance to the communities at
highest risk;

Enhancing recruitment and
retention efforts by increasing community buy-in and trust;

Enhancing the reliability and
validity of measurement instruments (particularly survey) through in-depth and
honest feedback during pre-testing;

Facilitating more effective
dissemination of research findings to impact public health and policy;

Increasing the potential for
translation of evidence-based research into sustainable community change that
can be disseminated more broadly.

For the purpose of this FOA,
“community” refers to populations that may be defined by: geography; race;
ethnicity; gender; sexual orientation; disability, illness, or other health
condition; or to groups that have a common interest or cause, such as health or
service agencies and organizations, health care or public health practitioners
or providers, policy makers, or lay public groups with public health concerns. “Community-based
organizations” refer to organizations that may be involved in the research
process as members or representatives of the community. While not an exhaustive
list, organizations as varied as Tribal governments and colleges, state or
local governments, independent living centers, other educational institutions
such as junior colleges, advocacy organizations, health delivery organizations
(e.g., hospitals), health professional associations, non-governmental
organizations, and Federally-qualified health centers are possible community
partners.

Several Institutes and Offices
within the National Institutes of Health (NIH, the Centers for Disease Control
and Prevention (CDC), and the Agency for Healthcare Research and Quality (AHRQ)
have joined together to support this initiative. Applications should be
relevant to both the objectives of the FOA and to at least one of the participating
organization's general research interests. Researchers are strongly encouraged
to both review the general research interests of the participating Institutes
supporting this FOA and to review the examples of topics of interest specific
to CBPR (shown below). As additional research areas are welcome, prospective
applicants are encouraged to contact the relevant program administrator for
this FOA as listed in Section VII prior to preparing
an application. While not an exhaustive list, CBPR projects focused on the
following areas of health promotion, disease prevention, and health disparities
are encouraged:

Agency for Healthcare
Research and Quality (AHRQ)

In accordance with the
goals of the New Freedom Initiative, AHRQ (http://www.ahrq.gov/)
is interested in community-based participatory research efforts targeted
towards increasing health promotion and prevention of secondary conditions in
persons with disabilities through community-partnered evaluation of supports
and access, and developing or assessing strategies to improve quality of care
and reduce disparities for persons with disabilities.

Persons with disabilities
are individuals that have limitations in major life activities. Secondary
conditions may be multi-dimensional, and include non-medical events (i.e.
isolation); conditions that affect the general population (i.e. obesity); and
problems that arise at any time during the lifespan, (i.e., inaccessible
examination equipment) (CDC, 2003). Community-based research partnerships with
disability advocacy groups offer the opportunity to address the self-identified
priorities of persons with disabilities; examine access to services and
facilities; develop and test patient-centered approaches; or adapt
evidence-based or prevention strategies to meet the needs of persons with
disabilities.

Research proposals may
include examination of:

Effectiveness of prevention
guidelines or strategies in decreasing risk behaviors and promoting health of
persons with disabilities;

Utilization of consumer
assessment of health plans by persons with disabilities to improve the quality
of health care delivery;

Use of community “built”
environment checklists to effectively identify barriers and supports to health
care facilities and services to persons with disabilities;

Identification of training needs
of providers in community-based service provision for persons with
disabilities;

Approaches to the reduction of
disparities among racial, ethnic, and socioeconomic subgroups of persons with
disabilities; or

Opportunities to identify
factors that assist in explaining under utilization or over utilization of
community-based services by persons with disabilities.

National Cancer
Institute (NCI)

The Department of Health
and Human Services (HHS) recently announced a trans-HHS report entitled:
“Making Cancer Health Disparities History” (http://www.chdprg.omhrc.gov/).
In this report, a broad coalition of scientists, practitioners, community and
patient advocates organized by the NCI (http://www.nci.nih.gov/)
identified several research themes that would best be addressed through a CBPR
model. These include, but are not limited to:

The need for more cancer
prevention and health promotion (e.g., tobacco control, diet/physical activity
to reduce obesity) research in medically underserved populations such as
racial/ethnic minorities, and low SES populations (e.g., rural poor).

Studies that develop standards
and test models for ensuring cultural competence in the delivery of prevention,
early detection, treatment and cancer survivorship services.

Studies that identify and test
strategies for overcoming the barriers (e.g., unequal service resource
allocation, cost-effectiveness) to the adoption of evidence-based interventions
in medically underserved communities.

Developing and testing
models in medically underserved communities (e.g., patient navigation) to
enhance access to and utilization of high quality cancer screening, diagnostic,
treatment, and survivor support services.

National Institute for
Occupational Safety and Health (NIOSH)

The NIOSH (http://www.cdc.gov/niosh/homepage.html)
is the Federal agency responsible for conducting research and making
recommendations for the prevention of work related injury and illness. The NIOSH
provides national leadership to prevent work-related illness and injury through
research, education, training, and prevention/intervention. One of the National
Occupational Research Agenda (NORA) priorities is Special Populations at Risk.
These populations are defined as groups of workers who have (1) biological,
social, or economic characteristics that place them at increased risk of
developing work-related conditions and (2) inadequate information collected
about them in the past. They may be disproportionately exposed to hazards and
unusually vulnerable to exposures. And they may have less access to or lower
quality of care after acquiring an illness or injury. These special populations
include minority workers, female workers, younger and older workers, workers
with medical or genetic susceptibility, workers with disabilities, immigrant
workers, and migrant and agricultural workers. These populations are often
employed in some of the most dangerous occupations including farming, mining,
manufacturing, and day labor. Some work-related illnesses identified include
silicosis, lead poisoning, musculoskeletal disorders, and pesticide-related
illnesses. Many conferences and reviews have contributed to identifying the
health and safety research needs of these unique or special populations at risk
(National Occupational Research Agenda Update July, 1997; 1998). However,
community involvement and contributions in identifying workplace injury and
illness concerns has been limited.

In addition, there is an
identified need for minority and underrepresented professionals who bring
multi-cultural and multi-ethnic experiences to address the research needs of
these specific worker populations. The NIOSH is committed to the support of
programs designed to increase the number of underrepresented, minority, and
female scientists participating in occupational health and safety research.
Therefore, applications from under-represented individuals are encouraged to
apply.

Types of research that
may be proposed include, but are not limited to:

Identify occupational jobs and
conditions in which large disparities in risk, exposure, and prevention exist
for various racial, ethnic, and gender groups, including approaches for
detecting, diagnosing, preventing and treating occupational disease and injury.

Translation of safety training
research findings to identified special populations. Develop tools to translate
health and safety research findings to underserved or underrepresented
populations.

Identification and perceptions
by these populations of work organization risk factors to safety and health
including development of appropriate interventions (protective equipment,
training, and best work practices).

Impact of work on the older
workforce (psychosocial work environment, role of occupation in health
disparities, employment barriers)

Incidence of health outcomes in
the underserved workforce, such as cardiovascular disease, obesity, cancer,
mental health, and access to health care.

In addition to the
preceding areas of emphasis, R21 research projects solicited in FOA PAR-06-247 might be
particularly suitable for addressing such issues as the following:

Exploratory methodological
studies: examination of the CBPR approach as an innovative methodology to use
in a scientific area;

The development and enhancement
of the CBPR process (e.g. issues of consent, IRB processes, the development of
new community-researcher partnerships, etc.), in epidemiological, prevention
research, intervention research, or health services research.

Add other general purposes for
which the R21 application may be well-suited, such as getting partnerships off
the ground.

Note: R01 applications
can consider adding a component to address the above issues.

National Institute of Child Health and Human Development (NICHD)

The NICHD (http://www.nichd.nih.gov/) is interested
in research projects of child health and development that are community based,
community level and/or community participatory. Studies are encouraged that
examine:

The interrelationship of
socio-economic status and/or poverty with community factors on child health and
development;

The interrelation of community
interactions as explanations of health disparities in children and young
adults;

The community's influence on
children's understanding of health and illness and how that understanding relates
(translates) to health behavior;

The impact of community
influences on the physiology of pregnancy and the infant in relation to health
outcome;

Community influences on
fertility, maternal health during pregnancy, labor, delivery and postpartum
periods, breast feeding patterns, and nurturing and rearing of infants and
children by both parents- especially, fathers;

The role of community with
respect to health-related beliefs or attitudes on achieving and maintaining
health and well-being of children and youth with physical, learning or
developmental disabilities;

Community influences on children
with physical disabilities caused by injury and their adaptation to the
impairments.

National Institute on Deafness and Other Communication Disorders (NIDCD)

The National Institute on Deafness and Other Communication Disorders (NIDCD), http://www.nidcd.nih.gov, supports basic and clinical biomedical and behavioral research in the communication sciences of hearing, balance, smell, taste, voice, speech and language. In April of 2004, the NIDCD sponsored a workshop on Translational Research in Hearing and Balance. Recommendations focusing on emergence into clinical practice included the need to increase dissemination of research evidence (i.e., promote systematic reviews of evidence, identify evidence needs in priority areas), promote the use of participatory research methods (i.e., alignments with advocacy groups), and continue to support research in health communication. The minutes from that workshop are available: (http://www.nidcd.nih.gov/funding/programs/tr/trminutes.asp)

NIDCD participation in this program announcement is an effort to be responsive to the workshop recommendations. NIDCD is interested in research projects in hearing, balance, smell, taste, voice, speech and language that include community participation. Examples of such studies include:

Development of tools to translate NIDCD research findings to special populations or underserved or underrepresented populations.

Development or enhancement of CBRP processes (e.g. issues of consent, IRB processes, development of new community-researcher partnerships) in NIDCD supported areas.

Exploration of community influences on individuals with deafness and other communication disorders and their adaptation to the disorder and habilitation/rehabilitation.

Exploration of approaches to increase the recruitment and retention of women, minorities and those with deafness and other communication disorders in NIDCD supported research.

Development and evaluation of methods to improve implementation of prevention and health promotion strategies by a wide range of organizations, agencies, institutions, health care professionals and providers, and others in the community.

National Institute of
Dental and Craniofacial Research (NIDCR)

The U.S. Surgeon
General's Report “Oral Health in America” acknowledges the consequential
disparities in oral health status that exist within vulnerable populations and
affects important aspects of quality of life including substantial pain,
inability to chew and diminished social interaction. Increasingly oral health
is associated with systemic health including low 5- year survival for those
with oral and pharyngeal cancer, the relationship between tooth loss and
nutritional outcomes, and the bi-directional relationship between periodontal
disease and diabetes. Racial and ethnic minorities, the poor, those with
acquired or developmental disabilities, the immunocompromised and frail and
dependent elders often suffer the worst oral health. The Report is emphatic that
to improve quality of life and eliminate oral health disparities health
professionals, individuals and communities must work together. The NIDCR’s (http://www.nidcr.nih.gov/) Plan to
Eliminate Craniofacial, Oral and Dental Health Disparities focuses the
research community's attention on oral infectious diseases (Early Childhood
Caries, coronal caries, and periodontal diseases) and oral and pharyngeal
cancer http://www.nidcr.nih.gov/NR/rdonlyres/54B65018-D3FE-4459-86DD-AAA0AD51C82B/0/hdplan.pdf.

Examples of the types of
research that would be responsive to this funding opportunity include, but are
not limited to:

Development of culturally
appropriate methods for assessing determinants of oral health, oral
health-related quality of life, and health outcomes in vulnerable populations.

Epidemiologic studies designed
to determine disease incidence and prevalence in vulnerable populations and
simultaneously examine the broad array of potential determinants of oral health
disparities.

Studies that explore approaches
to increase the recruitment and retention of women and minorities, those with
disabilities and vulnerable populations in oral health clinical research.

Development and testing of
innovative approaches to address environmental, social, behavioral and
biological determinants of disparities in oral health and oral health-related
quality of life.

Proposals involving a
clinical trial design will not be considered responsive to this FOA for the
NIDCR.

National Institute of
Environmental Health Sciences (NIEHS)

To help reduce the burden
of environmentally associated diseases and health conditions, the NIEHS (http://www.niehs.nih.gov/) promotes the
use of the CBPR process to: 1) provide the scientific basis for understanding
the impact of the environment on human health; 2) translate this information
into prevention and intervention strategies; 3) evaluate the efficacy of
prevention and intervention strategies; and 4) communicate the results to the
public and improve public health. For further information on the CBPR Program
at NIEHS, see: http://www.niehs.nih.gov/translat/cbpr/cbpr.htm.
There are disproportionate sitings of hazardous waste facilities, landfills and
manufacturing/industrial facilities in underserved or vulnerable communities
(based on race, ethnicity, gender, immigration status and/or SES). In many of
these communities, there are disparate outcomes from exposures based on
individual susceptibility that may result in a variety of adverse health
outcomes such as birth defects, premature birth, diabetes, cancer,
cardiovascular), pulmonary, and auto-immune diseases. NIEHS encourages a broad,
comprehensive approach to this problem that emphasizes both education and
research. Examples of projects that would be considered responsive to this FOA include,
but are not limited to the following:

Development of efficacious
methods for risk and/or exposure assessment in low-income and underserved
communities impacted by environmental hazards (including but not limited to
chemical exposures, the built environment, etc).

Develop innovative community
based approaches to address environmental determinants (particularly the
interaction between biological and environmental factors) of health disparities
and health outcomes.

Development of community-based,
culturally sensitive research agendas to address environmental risks to
mitigate adverse health effects from environmental exposures.

These community-based
prevention/intervention research projects should expand our knowledge and
understanding of the potential causes and remedies of environmentally related
disorders, while at the same time enhancing the capacity of communities to
participate in the processes that shape research approaches and intervention
strategies. Projects are encouraged to include a comprehensive plan to have an
ongoing evaluation from the inception of the project to its completion –
including but not limited to an assessment of the partnership among various
team members and policy and public health impact. It is highly recommended that
proposals make recommendations for future activities, beyond the period of
current funding, to assure continued participation of community members in
research and service programs addressing environmental injustices.

National Institute of Nursing Research (NINR)

The NINR has a history of
encouraging community-partnered research to promote health and to decrease
health disparities. The NINR's scientific program areas (http://www.ninr.nih.gov/) include
neurofunction and sensory conditions, reproductive health and child health
promotion, immune responses (including HIV/AIDS) and oncology, cardiopulmonary
health, chronic illness management, and end-of-life care. Developmental and
intervention research in any of these areas that clearly incorporate
communities as partners would be of interest to NINR. The following are
potential examples of research related to this program announcement. These
examples are not listed in any priority order and are not to be viewed as
exhaustive or all-inclusive.

Development and testing of
culturally relevant measures of clinical and cost outcomes of
community-partnered interventions aimed at reducing health disparities.

Intervention studies designed to
reduce risk factors and risk exposures that contribute to major areas of
concern relevant to the NINR scientific program areas noted above (e.g.,
cardiovascular disease, diabetes, HIV/AIDS, cancer screening and management,
infant mortality, or immunization).

Intervention studies to enhance
health seeking and health maintenance behaviors that incorporate the
sociocultural attributes and cultural norms and values of communities and their
members.

Intervention studies devoted to
preventing, reducing, or ameliorating health behaviors associated with such
major contributors to morbidity and mortality as tobacco use, diet and activity
patterns, interpersonal violence, or risky sexual behavior.

Innovative intervention studies
using technology to monitor and/ or facilitate the management of chronic
illness among identified communities and their members.

National Institute on
Alcohol Abuse and Alcoholism (NIAAA)

The NIAAA (http://www.niaaa.nih.gov/) is interested
in community participation in interventions to reduce heavy drinking and
alcohol-related problems and promote healthy lifestyles in communities,
especially where health disparities exist. Community- based participatory
research has the potential to reduce development of alcohol use disorders,
alcohol-related injuries and fatalities and delay or prevent underage drinking
and alcohol-related problems such as violence, unplanned pregnancies, sexually
transmitted diseases, and alcohol-related medical and psychiatric disorders.
These are areas in which the active participation of both communities and
researchers may enhance the development of innovative research approaches.
Community involvement facilitates the development and testing of interventions
in settings that are particularly relevant to health promotion as well as
reducing health disparities. Research is also needed on the relative
effectiveness and acceptability of different implementation strategies in
diverse population groups.

Research is needed to
develop and test community-level strategies that reduce alcohol-related
problems and their consequences, including person-focused interventions and
changes in alcohol policy, regulation, or pricing. Interventions that can be
transferred to other communities are especially important. Interventions should
be acceptable to communities, feasible in terms of available economic and
technical resources, and sustainable over time. Suggested strategies include,
but are not limited to:

Research that evaluates
collaborative community-based interventions that combine the efforts of
community, schools, family, media, and/or law enforcement to reduce or prevent
underage access to alcohol.

Research that develops and tests
community-based primary and secondary prevention efforts to reduce risky
behaviors such as driving after drinking and binge drinking.

Research that investigates
changes in alcohol price and/or availability, changes in alcohol-related laws
and regulations, and the impact of these changes on underage access to alcohol,
alcohol-related traffic injuries and fatalities, alcohol-related non-traffic
injuries, and alcohol-related violence.

Research that addresses the
impact of access to alcohol prevention, early intervention and other treatment
services on health promotion, disease prevention and the level of health
disparities within communities.

Research that studies the
translation and dissemination of effective alcohol-reduction strategies and
interventions from one community to another.

Research that specifically
focuses on questions identified as crucial by discrete communities as defined
by geography, culture, demographic commonality or shared interest.

National Heart, Lung,
and Blood Institute (NHLBI)

Increasing evidence
demonstrates the important role of individual and community level behaviors in
influencing the course of cardiovascular, lung, and blood diseases. To promote
the development of innovative strategies for improving public health, the NHLBI
(http://www.nhlbi.nih.gov/) encourages
scientific research that includes the community of interest in the
determination of the goals, design, implementation, and interpretation of the
research. Research is needed not only to develop and evaluate new intervention
strategies, but also to test the feasibility and effectiveness of
community-based participatory approaches to the research endeavor. Examples of
potential research topics that would be responsive to the NHLBI's interest in
this FOA include, but are not limited to, the following:

Evaluate methods to overcome
barriers in the translation of clinical guidelines to patients and clinicians
for obesity and prevention and treatment of hypertension in community settings.

Examine the use of CBPR
approaches in large scale social marketing projects in diverse community that
target environmental and societal changes to promote healthy weight levels.

Evaluate school based
interventions to promote prevention and treatment of hypertension and/or
obesity.

Examine the effectiveness of
support groups for adults with sickle cell diseases in improving quality of
life, coping skills, and health behaviors.

Examine the effectiveness of
life skills training for adolescents with hereditary blood disorders.

Compare educational
interventions to help children with hereditary blood disorders function at
grade level and avoid poor school performance and failure.

Develop and evaluate community
based pain management programs for adults with sickle cell disease.

Develop and evaluate donor
recruitment programs for racial/ethnic groups that are underrepresented in
blood and bone marrow donation programs.

Evaluate the benefits of
community based, system wide approaches to improving the asthma care available
to and effectively used by patients at high risk of asthma morbidity (e.g.
programs that link school/workplace, medical, and family/neighborhood efforts
in the community).

Evaluate community center health
workers, lay opinion leader, or other community centered interventions to
improve families' management of a child's asthma.

Evaluate the integration of
asthma programs with community services for other chronic illness or public
health programs to improve life-skills training (e.g. community recreational
sports programs; parenting classes; after-school programs or early childhood
education classes).

National Institute of
Mental Health (NIMH)

The NIMH (http://www.nimh.nih.gov) has a long history
of concern and action related to health disparities and racial/ethnic
populations as well as other underrepresented groups (i.e., women, children,
disabled) for both its mental health and HIV/AIDS research agendas. Disparities
research for mental health and HIV/AIDS outcomes takes into consideration
relevant complex factors that influence disparities in services, particularly
across special population groups, as well as women and children, and persons
living in rural and frontier areas. A range of effective preventive
interventions that can be transferred to the community must be implemented in
view of the burden from unequal access to health care resources,
disproportionate impact of comorbid conditions, and marginalization of
subpopulations within these communities. Additionally, disparities in services
research addresses care delivered in a variety of settings such as the
specialty mental health sector, the general medical sector, and community
settings (e.g., schools). Also, it supports research that examines innovative
services interventions (e.g., community-based participatory methods,
faith-based) to overcome disparities related to mental health and HIV service
delivery and use.

Some types of research
areas that may be proposed include, but are not limited to:

Studies to address the reduction
of disparities in services using multi-level interventions (e.g.,
organizational and community; interpersonal and socio-cultural).

Use of community-based
participatory research techniques to enhance the relevance of research
questions and improve uptake of findings.

Adaptation of evidence- based
practices to new settings and populations.

Development of research on how
individual, socio-cultural, and organizational contexts affect access to, use
of, and perceptions of mental heath services for racial/ethnic populations with
cross-disciplinary translational approaches.

Identification of factors that
overcome health disparities relevant to health service delivery and use by
ethnic minority populations to determine why there are disparities in access to
and in the use of mental health and mental health related services within and
across ethnic racial/ethnic populations. Also, determine the deferential
patterns of mental health service utilization across racial/ethnic populations
and majority populations.

Dissemination of effective
prevention interventions to racial and ethnic minority communities through
community based organizations, providers of mental health and/or HIV-related
care and services, and minority predominant and minority serving institutions.

Projects to facilitate the
establishment of research partnerships between minority institutions and the
communities they serve by enhancing and expanding initiatives that support
mental health and HIV-related research in minority communities.

National Institute on Drug Abuse (NIDA)

The NIDA (http://www.nida.nih.gov/)
has a long tradition of involving the community in its efforts to understand,
reduce, prevent, and treat drug abuse and its adverse health and social
consequences. Involving community partners and collaborators in drug abuse and
HIV/AIDS research, for example, has informed NIDA's efforts to develop and
implement culturally appropriate, community-based HIV/AIDS outreach
interventions to avert the spread of new HIV infections among drug users,
particularly in communities where health disparities exist. When drug abuse
prevention and treatment programs are developed with the community's
participation, the community becomes instrumental in their successful
implementation and acceptance. Community-based participatory research has
contributed to NIDA's mission to improve the effectiveness of drug abuse
prevention and services programs in reaching persons at highest risk.

The NIDA is interested in community-based, community
level, and/or community participatory research on drug abuse, drug addiction,
and drug-use related health and social consequences, and in the development of
effective strategies to promote drug-free lifestyles, prevent drug abuse and
its consequences, and eliminate health disparities. Studies are encouraged that
examine:

Community factors related
to drug abuse, addiction, and its associated adverse behavioral, social,
and health outcomes within and across racial/ethnic minority populations
and their communities;

The interrelationships of
community characteristics, including structural factors (socioeconomic
status, community resources, and environmental characteristics) on drug
abuse and the transmission of HIV/AIDS and other infectious diseases;

Community norms,
attitudes, and beliefs toward drug abuse and addiction, drug-related
activity, policing activities, and the establishment and maintenance of
prevention programs and treatment services in the neighborhood;

Strategies to improve and
develop innovative community-partnered approaches to enhance long-term
community-based participation in research on drug abuse and its health and
social consequences, including the implementation of sustainable
prevention, treatment, and services programs.

This FOA will use the NIH Research Project Grant (R01) award mechanism.

The
applicant will be solely responsible for planning, directing, and executing the
proposed project.

This FOA uses “Just-in-Time” information
concepts. It also uses the modular as well as the
non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are a U.S. organization
and are submitting an application with direct costs in each year of $250,000 or
less (excluding consortium Facilities
and Administrative [F&A] costs), use the PHS398 Modular Budget component
provided in the SF424 (R&R) Application Package and SF424 (R&R)
Application Guide (see specifically Section 5.4, “Modular Budget Component,” of
the Application Guide).

U.S. applicants
requesting more than $250,000 in annual direct costs and all foreign applicants
must complete and submit budget requests using the Research & Related
Budget component found in the application package for this FOA. See NOT-OD-06-096,
August 23, 2006.

2.
Funds Available

Because the nature and scope
of the proposed research will vary from application to application, it is
anticipated that the size and duration of each award will also vary. Although
the financial plans of the Institutes and Centers (ICs) provide support for
this program, awards pursuant to this funding opportunity are contingent upon
the availability of funds and the submission of a sufficient number of
meritorious applications.

NIH grants policies as described in the NOT-OD-05-004,
November 2, 2004.

Section
III. Eligibility Information

1. Eligible Applicants

1.A. Eligible
Institutions

You
may submit (an) application(s) if your organization has any of the following
characteristics:

Indian/Native American Tribal Government (Other than
Federally Recognized)

Indian/Native American Tribally Designated
Organization

Non-domestic (non-U.S.) Entity (Foreign Organization)

Hispanic-serving Institution

Historically Black Colleges and Universities (HBCUs)

Tribally Controlled Colleges and Universities (TCCUs)

Alaska Native and Native
Hawaiian Serving Institutions

Regional Organization

Other(s):Eligible agencies of the Federal government;
Faith-based or community based organizations; independent living centers; advocacy
or research organizations; health delivery organizations (e.g., hospitals); and
health professional associations are eligible institutions or possible
community partners.

1.B.
Eligible Individuals

Any individual with the skills, knowledge, and
resources necessary to carry out the proposed research is invited to work with
their institution to develop an application for support. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH programs.

More than one PD/PI, or
multiple PDs/PIs, may be designated on the application for projects that
require a “team science” approach that clearly does not fit the single-PD/PI
model. Additional information
on the implementation plans and policies and procedures to formally allow more
than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi.All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to
apply for a single PD/PI or multiple PD/PI grant is the responsibility of the
investigators and applicant organizations and should be determined by the
scientific goals of the project. Applications for multiple PD/PI grants will
require additional information, as outlined in the instructions below. The NIH
review criteria for approach, investigators, and environment have been modified
to accommodate applications involving either a single PD/PI or multiple PDs/PIs.
When considering multiple PDs/PIs, please be aware that the structure and
governance of the PD/PI leadership team as well as the knowledge, skills and
experience of the individual PD/PIs will be factored into the assessment of the
overall scientific merit of the application. Multiple PDs/PIs on a project
share the authority and responsibility for leading and directing the project,
intellectually and logistically. Each PD/PI is responsible and accountable
to the grantee organization, or, as appropriate, to a collaborating
organization, for the proper conduct of the project or program, including the
submission of required reports. For further information on multiple PDs/PIs,
please seehttp://grants.nih.gov/grants/multi_pi.

At this time, it
is not known if competing renewal (formerly “competing continuation”)
applications will be accepted and/or if this FOA will be reissued.

Applicants may submit more than one application, provided each application is scientifically distinct.

The
investigators for each research proposal must define the relevant community or
communities for their study using a set of tangible and explicit criteria. The
criteria can include a common interest, identity, characteristic, or condition.
They must also clearly identify who from that community will be included as
participants in the research process. It is typically ideal in participatory
research for the community in which the study is based to be involved in all or
most phases of the research process. In some cases, however, it may not be
possible for participants to be involved in all phases, or participants
themselves may choose not to be involved in one or more phases. The absolute
minimum involvement that can still be considered as participatory research is
for participants to be involved at the front end of the study in helping to
identify the research questions of most importance to the community, and then
also at the back end in helping to interpret and apply the research findings to
ensure that they maintain their relevance for the community. The investigators
for each proposal must identify in which phases of the research community
members are engaged as participants.

Applicants
must describe an existing or proposed involvement with one or more
community-based organizations. This connection is essential to the development
of community-based approaches and should also enhance the potential for
long-term impact of the project. It is also essential that all facets of the
project design be educationally and culturally appropriate, as well as
appropriate to participants' ability. Letters of support from each partnering
community, that describe the working relationships with the researcher, should be
provided.

The following
two elements should also be considered in the 25 page limit of the PHS398
Research Plan component for applications submitted in response to this FOA.

An Assessment Plan Identify the means of establishing effective
input from a community on matters such as priority areas of health or plausible
approaches and constraints in addressing health concerns. In addition to
providing funding for the time and effort of the community partners who are
serving as co-investigators on the project (including the cost of providing
respite care for those projects focused on a disability community), applicants
are encouraged to create a community-based advisory board or steering committee
to facilitate planning, education, outreach, dissemination, and evaluation
efforts. Input could be obtained directly from members of a community as well
as from representatives of such groups as community and neighborhood
associations, churches, public housing resident councils, community health
centers, local public health service departments, independent living centers,
schools, and minority educational institutions.

A Communication and Dissemination Plan Describe the methods and
process for dissemination within the community.

Required Personnel

Although a single institution or organization must be
the applicant, a multi-institutional arrangement (consortium) is possible. Such
consortia, entailing active participation by more than one organization, are
encouraged if there is clear evidence of close interaction and responsible
partnership among the participants.

It is important to note that, because of the wide
range of health problems to be addressed and the diversity of affected
communities, applications must include at least one of each of the following:

A research scientist (e.g., an epidemiological or behavioral or
social scientist, etc.) familiar with CBPR.

A member of a community organization in an area having the study
population. This individual must be someone who lives in or works directly and
regularly with the participating community.

In the case of intervention research, a representative of
the community institutions involved in conducting the intervention activity.

The individual(s) designated as
PDs/PIs on the application must also be registered in the NIH eRA Commons. In the case of multiple PDs/PIs, all PDs/PIs must be registered and be assigned
the PI role in the eRA Commons prior to the submission of the application.

Each PD/PI must
hold a PD/PI account in the Commons. Applicants should not share a Commons account for both an Authorized Organization
Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have both a
PD/PI role and an Internet Assisted Review (IAR) role, both roles should exist
under one Commons account.

When multiple PDs/PIs are
proposed, all PDs/PIs at the applicant organization must be affiliated with
that organization. PDs/PIs located at another institution need not be
affiliated with the applicant organization, but must be affiliated with their
own organization to be able to access the Commons.

This registration/affiliation must
be done by the AOR/SO or their designee who is already registered in the Commons.

Both the PD/PI(s) and
AOR/SO need separate accounts in the NIH eRA Commons since both are authorized
to view the application image.

Note that if a PD/PI is
also an NIH peer-reviewer with an Individual DUNS and CCR registration, that
particular DUNS number and CCR registration are for the individual reviewer only.
These are different than any DUNS number and CCR registration used by an
applicant organization. Individual DUNS and CCR registration should be used
only for the purposes of personal reimbursement and should not be used on any
grant applications submitted to the Federal Government.

Several of the steps of
the registration process could take four weeks or more. Therefore, applicants
should immediately check with their business official to determine whether
their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept
electronic applications only from organizations that have completed all
necessary registrations.

1. Request Application Information

Applicants must
download the SF424 (R&R) application forms and the SF424 (R&R)
Application Guide for this FOA through Grants.gov/Apply.

Note:
Only the forms package directly attached to a specific FOA can be used. You
will not be able to use any other SF424 (R&R) forms (e.g., sample forms,
forms from another FOA), although some of the "Attachment" files may
be useable for more than one FOA.

Prepare all
applications using the SF424 (R&R) application forms and in accordance with
the SF424 (R&R) Application Guide for this FOA
through Grants.gov/Apply.

The SF424 (R&R)
Application Guide is critical to submitting a complete and accurate application
to NIH. There are fields within the SF424 (R&R) application components
that, although not marked as mandatory, are required by NIH (e.g., the
“Credential” log-in field of the “Research & Related Senior/Key Person
Profile” component must contain the PD/PI’s assigned eRA Commons User ID).
Agency-specific instructions for such fields are clearly identified in the
Application Guide. For additional information, see “Frequently Asked Questions
– Application Guide, Electronic
Submission of Grant Applications.”

The SF424 (R&R)
application has several components. Some components are required, others are
optional. The forms package associated with this FOA in Grants.gov/APPLYincludes all applicable components, required and optional. A completed
application in response to this FOA includes the data in the following
components:

Prepare detailed budgets for all
applications (that is, complete the Research & Related Budget
component of the SF424 (R&R) application forms – not the PHS398
Modular Budget component). See NOT-OD-06-096.

Charge back
of customs and import fees is not allowed.

Format: Every
effort should be made to comply with the format specifications, which are
based upon a standard U.S. paper size of 8.5” x 11” within each PDF.

Funds for up
to 8% administrative costs (excluding equipment) may be requested. SeeNOT-OD-01-028, March 29, 2001.

Organizations
must comply with Federal/NIH policies on human subjects, animals, and
biohazards.

Organizations
must comply with Federal/NIH biosafety and biosecurity regulations. See Section
VI.2., “Administrative and National
Policy Requirements.”

Proposed
research should provide special opportunities for furthering research programs
through the use of unusual talent, resources, populations, or environmental
conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

SPECIAL INSTRUCTIONS

Applications with
Multiple PDs/PIs

When multiple PDs/PIs are
proposed, NIH requires one PD/PI to be designated as the "Contact” PI, who
will be responsible for all communication between the PDs/PIs and the NIH, for
assembling the application materials outlined below, and for coordinating
progress reports for the project. The contact PD/PI must meet all eligibility
requirements for PD/PI status in the same way as other PDs/PIs, but has no
other special roles or responsibilities within the project team beyond those
mentioned above.

Information for the Contact
PD/PI should be entered in item 15 of the SF424 (R&R) Cover
component. All other PDs/PIs should be listed in the Research &
Related Senior/Key Person component and assigned the project role of “PD/PI.” Please
remember that all PDs/PIs must be registered in the eRA Commons prior to
application submission. The Commons ID of each PD/PI must be included in the “Credential” field of the Research &
Related Senior/Key Person component. Failure to include this data field
will cause the application to be rejected.

All projects proposing Multiple PDs/PIs will be
required to include a new section describing the leadership of the project.

Multiple PD/PI Leadership Plan: For applications designating
multiple PDs/PIs, a new section of the research plan, entitled “Multiple PD/PI
Leadership Plan” (Section 14 of the Research Plan Component in the SF424
(R&R)), must be included. A rationale for choosing a multiple PD/PI
approach should be described. The governance and organizational structure of
the leadership team and the research project should be described, including
communication plans, process for making decisions on scientific direction, and
procedures for resolving conflicts. The roles and administrative,
technical, and scientific responsibilities for the project or program should be
delineated for the PDs/PIs and other collaborators.

If budget allocation
is planned, the distribution of resources to specific components of the project
or the individual PDs/PIs should be delineated in the Leadership Plan. In the
event of an award, the requested allocations may be reflected in a footnote on
the Notice of Award.

Applications Involving a Single Institution

When all PDs/PIs are
within a single institution, follow the instructions contained in the SF424
(R&R) Application Guide.

Applications Involving Multiple Institutions

When multiple institutions
are involved, one institution must be designated as the prime institution and
funding for the other institution(s) must be requested via a subcontract to be
administered by the prime institution. When submitting a detailed budget, the
prime institution should submit its budget using the Research & Related
Budget component. All other institutions should have their individual
budgets attached separately to the Research & Related Subaward Budget
Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application
Guide for further instruction regarding the use of the subaward budget
form.

When submitting a modular budget, the prime institution
completes the PHS398 Modular Budget component only. Information concerning
the consortium/subcontract budget is provided in the budget justification. Separate
budgets for each consortium/subcontract grantee are not required when using the
Modular budget format. See Section 5.4 of the Application Guide for further
instruction regarding the use of the PHS398 Modular Budget component.

Prospective applicants are
asked to submit a letter of intent that includes the following information:

Descriptive title of
proposed research

Name, address, and
telephone number of the Principal Investigator

Names of other key
personnel

Participating institutions

Number and title of this
funding opportunity

Although a letter of intent is not required, is not
binding, and does not enter into the review of a subsequent application, the
information that it contains allows IC staff to estimate the potential review
workload and plan the review.

The letter of intent is to be sent by the date listed at
the beginning of this document.

In order to expedite the review, applicants are
requested to notify the Office
of Behavioral and Social Sciences Research Referral Office
by emailPhilogeS@od.nih.gov) when the
application has been submitted. Please include the FOA number and
title, PD/PI name, and title of the application.

3.C.
Application Processing

Applications may be submitted on or after the opening date and must be
successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt
date(s) and time, the application may be delayed in the review process or not
reviewed.

Once an application
package has been successfully submitted through Grants.gov, any errors have
been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have
two business days to view the application image.

If
everything is acceptable, no further action is necessary. The application will
automatically move forward for processing by the Division of Receipt and
Referral, Center for Scientific Review, NIH, after two business days.

Prior
to the submission deadline, the AOR/SO can “Reject” the assembled application
and submit a changed/corrected application within the two-day viewing window.
This option should be used if the AOR/SO determines that warnings should be
addressed or if information was lost or compromised during transmission.
Reminder: warnings do not stop further application processing. If an
application submission results in warnings (but no errors), it will
automatically move forward after two business days if no action is taken.
Please remember that some warnings may not be applicable or may need to be
addressed after application submission.

If
the two-day window falls after the submission deadline, the AOR/SO will have
the option to “Reject” the application if, due to an eRA Commons or Grants.gov
system issue, the application does not correctly reflect the submitted
application package (e.g., some part of the application was lost or didn’t
transfer correctly during the submission process). The AOR/SO should first
contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course
of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue.

If
the AOR/SO chooses to “Reject” the image after the submission deadline for a
reason other than an eRA Commons or Grants.gov system failure, a changed/corrected
application still can be submitted, but it will be subject to the NIH late
policy guidelines and may not be accepted. The reason for this delay should
be explained in the cover letter attachment.

Both
the AOR/SO and PD/PI will receive e-mail notifications when the application is
rejected or the application automatically moves forward in the process after
two days.

Upon receipt, applications will be evaluated for completeness
by the Center for Scientific Review, NIH, and for responsiveness by the Office
of Behavioral and Social Sciences Research. Incomplete and non-responsive
applications will not be reviewed.

There will
be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR receives
the Grants.gov acknowledgments. The AOR and the PI receive Commons
acknowledgments. Information related to the assignment of an application to a
Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the
responsibility of the applicant to check periodically on their application
status in the Commons.

The
NIH will not accept any application in response to this FOA that is essentially
the same as one currently pending initial merit review unless the applicant
withdraws the pending application. The NIH will not accept any application that
is essentially the same as one already reviewed. This does not preclude the
submission of an application already reviewed with substantial changes, but
such application must include an “Introduction” addressing the previous
critique. Note such an application is considered a "resubmission" for
the SF424 (R&R).

All
NIH awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants
Policy Statement.

Pre-award costs are allowable.
A grantee may, at its own risk and without NIH prior approval, incur
obligations and expenditures to cover costs up to 90 days before the beginning
date of the initial budget period of a new or competing renewal (formerly
“competing continuation”) award if such costs: are necessary to conduct the
project, and would be allowable under the grant, if awarded, without NIH prior
approval. If specific expenditures would otherwise require prior approval, the
grantee must obtain NIH approval before incurring the cost. NIH prior approval
is required for any costs to be incurred more than 90 days before the beginning
date of the initial budget period of a new or competing renewal award.

The incurrence of pre-award costs in anticipation of a competing or
non-competing award imposes no obligation on NIH either to make the award or to
increase the amount of the approved budget if an award is made for less than
the amount anticipated and is inadequate to cover the pre-award costs incurred.
NIH expects the grantee to be fully aware that pre-award costs result in
borrowing against future support and that such borrowing must not impair the
grantee's ability to accomplish the project objectives in the approved time
frame or in any way adversely affect the conduct of the project. See theNIH Grants
Policy Statement.

The
applicant organization must include its DUNS number in its Organization Profile
in the eRA Commons. This DUNS number must match the DUNS number provided at CCR
registration with Grants.gov. For
additional information, see “Frequently Asked Questions – Application Guide, Electronic
Submission of Grant Applications.”

PHS398 Research Plan Component Sections

Items
2-5 of the PHS398 Research Plan component are limited to 25 pages. While each
section of the Research Plan component needs to be uploaded separately as a PDF
attachment, applicants are encouraged to construct the Research Plan component
as a single document, separating sections into distinct PDF attachments just
before uploading the files. This approach will enable applicants to better
monitor formatting requirements such as page limits. All attachments must be
provided to NIH in PDF format, filenames must be included with no spaces or
special characters, and a .pdf extension must be used.

All
application instructions outlined in the SF424 (R&R) Application Guide are
to be followed, incorporating "Just-in-Time" information concepts,
and with the following additional requirements:

R01
applications from U.S. institutions/organizations requesting up to $250,000 per
year in direct costs (excluding consortium F&A costs) must be submitted in
a modular budget format. Additional information on modular budgets is available
at http://grants.nih.gov/grants/funding/modular/modular.htm. When
submitting a modular budget, the applicant organization will include only the
PHS398 Modular Budget component. See Section 5.4 of the SF424 (R&R) Application Guide for further
instructions regarding the use of the PHS398 Modular Budget component.

Foreign organizations
may not submit modular budgets. See NOT-OD-06-096.

Special Instructions for Applications Requesting $500,000
(direct costs) or More Per Year

Applicants
requesting $500,000 or more in direct costs for any year (excluding consortium
F&A costs) must carry out the following steps:

1) Contact the
IC program staff at least 6 weeks before submitting the application, i.e., as
you are developing plans for the study;

2)
Obtain agreement from the IC staff that the IC will accept your application for
consideration for award; and,

3)
Include the PHS398 Cover Letter component with the application to identify the
staff member and IC who agreed to accept assignment of the application.

IMPORTANT NOTE: NIH has published new limitations on
grant application appendix materials to encourage applications to be as concise
as possible while containing the information needed for expert scientific
review.

Do not use the Appendix to circumvent the page limitations of
the Research Plan component. An application that does not observe the required
page limitations may be delayed in the review process.

Note:
While each section of the PHS398 Research Plan component needs to be uploaded
separately as a PDF attachment, applicants are encouraged to construct the
Research Plan component as a single document, separating sections into distinct
PDF attachments just before uploading the files. This approach will enable
applicants to monitor better formatting requirements such as page limits. All
attachments must be provided to NIH in PDF format, filenames must be included
with no spaces or special characters, and a .pdf extension must be used.

Foreign Applications (Non-domestic (non-U.S.) Entity)

Indicate how the proposed project has specific
relevance to the mission and objectives of the IC and has the potential
for significantly advancing the health sciences in the United States.

Plan for Sharing Research Data

The
precise content of the data-sharing plan will vary, depending on the data being
collected and how the investigator is planning to share the data. Applicants
who are planning to share data may wish to describe briefly the expected
schedule for data sharing, the format of the final dataset, the documentation
to be provided, whether or not any analytic tools also will be provided,
whether or not a data-sharing agreement will be required and, if so, a brief
description of such an agreement (including the criteria for deciding who can
receive the data and whether or not any conditions will be placed on their
use), and the mode of data sharing (e.g., under their own auspices by mailing a
disk or posting data on their institutional or personal Web site, through a
data archive or enclave). Investigators choosing to share under their own
auspices may wish to enter into a data-sharing agreement. References to data
sharing may also be appropriate in other sections of the application.

Applicants
requesting more than $500,000 in direct costs in any year of the proposed
research must include a plan for sharing research data in their application.
The funding organization will be responsible for monitoring the data sharing
policy (http://grants.nih.gov/grants/policy/data_sharing).

The reasonableness of the data sharing plan or the rationale
for not sharing research data may be assessed by the reviewers. However,
reviewers will not factor the proposed data sharing plan into the determination
of scientific merit or the priority score.

Sharing
Research Resources

NIH
policy expects that grant recipients make unique research resources readily
available for research purposes to qualified individuals within the scientific
community after publication (See the NIH Grants Policy Statementhttp://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.

The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each Non-Competing Grant
Progress Report (PHS 2590). See Section VI.3.,
“Reporting.”

Section V. Application Review Information

1.
Criteria

Only
the review criteria described below will be considered in the review process.

2.
Review and Selection Process

Applications
submitted for this funding opportunity will be assigned to the ICs on the basis
of established PHS referral guidelines.

Undergo
a selection process in which only those applications deemed to have the
highest scientific merit, generally the top half of applications under
review, will be discussed and assigned a priority score.

Receive
a written critique.

Receive a
second level of review by the appropriate national advisory council or
board.

Applications
submitted in response to this funding opportunity will compete for available
funds with all other recommended applications. The following will be considered
in making funding decisions:

Scientific
merit of the proposed project as determined by peer review.

Availability
of funds.

Relevance
of program priorities.

The goals of NIH
supported research are to advance our understanding of biological systems, to
improve the control of disease, and to enhance health. In their written
critiques, reviewers will be asked to comment on each of the following criteria
in order to judge the likelihood that the proposed research will have a
substantial impact on the pursuit of these goals. Each of these criteria will
be addressed and considered in assigning the overall score, weighting them as
appropriate for each application.

Significance

Approach

Innovation

Investigator

Environment

Note that an
application does not need to be strong in all categories to be judged likely to
have major scientific impact and thus deserve a high priority score. For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.

Significance:Does this study address an important problem? If
the aims of the application are achieved, how will scientific knowledge or
clinical practice be advanced? What will be the effect of these studies on the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

Approach:Are the
conceptual or clinical framework, design, methods, and analyses adequately
developed, well integrated, well reasoned, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics? For applications
designating multiple PDs/PIs, is the leadership approach, including the
designated roles and responsibilities, governance, and organizational structure,
consistent with and justified by the aims of the project and the expertise of
each of the PDs/PIs?

Innovation: Is the project
original and innovative? For example: Does the project challenge existing
paradigms or clinical practice; address an innovative hypothesis or critical
barrier to progress in the field? Does the project develop or employ novel concepts,
approaches, methodologies, tools, or technologies for this area?

Investigators:Are the PD/PI(s)
and other key personnel appropriately trained and well suited to carry out this
work? Is the work proposed appropriate to the experience level of the principal
investigator and other researchers? Does the PD/PI(s) and investigative team
bring complementary and integrated expertise to the project (if applicable)?

Environment: Do(es) the
scientific environment(s) in which the work will be done contribute to the
probability of success? Do the proposed studies benefit from unique features of
the scientific environment(s), or subject populations, or employ useful
collaborative arrangements? Is there evidence of institutional support?

2.A.
Additional Review Criteria

In addition to the above criteria, the
following items will continue to be considered in the determination of
scientific merit and the priority score:

Resubmission Applications (formerly
“revised/amended” applications): Are the responses to comments from the
previous scientific review group adequate? Are the improvements in the
resubmission application appropriate?

Protection
of Human Subjects from Research Risk: The involvement of human
subjects and protections from research risk relating to their participation in
the proposed research will be assessed. See the “Human Subjects Sections”
of the PHS398 Research Plan component of the SF424 (R&R)..

Inclusion of Women, Minorities and Children in Research: The adequacy of
plans to include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated. See the “Human Subjects Sections” of the PHS398 Research
Plan component of the SF424 (R&R)

Care and Use of Vertebrate Animals in Research: If vertebrate animals
are to be used in the project, the adequacy of the plans for their care and use
will be assessed. See the “Other Research Plan Sections” of the PHS398 Research
Plan component of the SF424 (R&R).

Biohazards: If materials or procedures are proposed that are potentially
hazardous to research personnel and/or the environment, determine if the
proposed protection is adequate.

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the
appropriateness of the requested period of support in relation to the proposed
research may be assessed by the reviewers. The priority score should not be
affected by the evaluation of the budget.

Applications from Foreign Organizations: Whether
the project presents special opportunities for furthering research programs
through the use of unusual talent, resources, populations, or environmental
conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed.

2.C.
Sharing Research Data

Data Sharing Plan: The reasonableness of the
data sharing plan or the rationale for not sharing research data may be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority score.
The funding organization will be responsible for monitoring the data sharing
policy. http://grants.nih.gov/grants/policy/data_sharing.

2.D. Sharing Research
Resources

NIH policy expects that
grant recipients make unique research resources readily available for research
purposes to qualified individuals within the scientific community after
publication (See the NIH Grants Policy Statementhttp://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.

Program staff will be
responsible for the administrative review of the plan for sharing research
resources.

The
adequacy of the resources sharing plan and any related data sharing plans will
be considered by Program staff of the funding organization when making
recommendations about funding applications. The effectiveness of the resource
sharing will be evaluated as part of the administrative review of each Non-Competing Grant
Progress Report (PHS 2590), See Section VI.3.,
“Reporting.”Model Organism Sharing Plan: Reviewersare
asked to assess the sharing plan in an administrative note. The sharing plan
itself should be discussed after the application is scored. Whether a sharing
plan is reasonable can be determined by the reviewers on a case-by-case basis,
taking into consideration the organism, the timeline, the applicant's decision
to distribute the resource or deposit it in a repository, and other relevant
considerations.

3.
Anticipated Announcement and Award Dates

Not Applicable

Section
VI. Award Administration Information

1.
Award Notices

After the peer review of the application
is completed, the PD/PI will be able to access his or her Summary Statement
(written critique) via the NIH eRA Commons.

A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via email
notification from the awarding component to the grantee business official.

Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Section
IV.5., “Funding Restrictions.”

We
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research, peer review, and financial or grants
management issues:

Human Subjects Protection:Federal regulations (45 CFR 46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies (Phase
I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials
(Phase III). Monitoring should be commensurate with risk. The establishment of
data and safety monitoring boards (DSMBs) is required for multi-site clinical
trials involving interventions that entail potential risks to the participants
(“NIH Policy for Data and Safety Monitoring,” NIH Guide for Grants and
Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their
institutions, on issues related to institutional policies and local IRB rules,
as well as local, State and Federal laws and regulations, including the Privacy
Rule. Reviewers will consider the data sharing plan but will not factor the
plan into the determination of the scientific merit or the priority score.

Access
to Research Data through the Freedom of Information Act:The Office of
Management and Budget (OMB) Circular A-110 has been revised to provide access
to research data through the Freedom of Information Act (FOIA) under some
circumstances. Data that are (1) first produced in a project that is supported
in whole or in part with Federal funds and (2) cited publicly and officially by
a Federal agency in support of an action that has the force and effect of law
(i.e., a regulation) may be accessed through FOIA. It is important for applicants
to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.

Sharing of
Model Organisms:NIH is committed
to support efforts that encourage sharing of important research resources
including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH
Grants Policy Statement. Beginning October 1, 2004, all investigators
submitting an NIH application or contract proposal are expected to include in
the application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications where
the development of model organisms is anticipated.

Inclusion of
Women And Minorities in Clinical Research:It is the policy
of the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a clear
and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of the
research. This policy results from the NIH Revitalization Act of 1993 (Section
492B of Public Law 103-43). All investigators proposing clinical research
should read the "NIH Guidelines for Inclusion of Women and Minorities as
Subjects in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the SF424 (R&R) application; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of
Children as Participants in Clinical Research:The NIH
maintains a policy that children (i.e., individuals under the age of 21) must
be included in all clinical research, conducted or supported by the NIH, unless
there are scientific and ethical reasons not to include them.

Required
Education on the Protection of Human Subject Participants:NIH policy
requires education on the protection of human subject participants for all
investigators submitting NIH applications for research involving human subjects
and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human
Embryonic Stem Cells (hESC):Criteria for
federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research. Applications that do not provide this
information will be returned without review.

NIH Public Access Policy:NIH-funded
investigators are requested to submit to the NIH manuscript submission (NIHMS) system
(http://www.nihms.nih.gov/) at PubMed
Central (PMC) an electronic version of the author's final manuscript upon
acceptance for publication, resulting from research supported in whole or in
part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.

NIH is
requesting that authors submit manuscripts resulting from 1) currently funded
NIH research projects or 2) previously supported NIH research projects if they
are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms,
cooperative agreements, contracts, Institutional and Individual Ruth L.
Kirschstein National Research Service Awards, as well as NIH intramural
research studies. The Policy applies to peer-reviewed, original research
publications that have been supported in whole or in part with direct costs
from NIH, but it does not apply to book chapters, editorials, reviews, or
conference proceedings. Publications resulting from non-NIH-supported research
projects should not be submitted.

For more
information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov// and view the Policy or other Resources and Tools, including the Authors' Manual.

Standards for Privacy of Individually Identifiable
Health Information:The Department
of Health and Human Services (HHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health
Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information, and is administered and enforced by the HHS
Office for Civil Rights (OCR).

Decisions about
applicability and implementation of the Privacy Rule reside with the researcher
and his/her institution. The OCR website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and
proposals for NIH funding must be self-contained within specified page
limitations. For publications listed in the appendix and/or Progress report,
Internet addresses (URLs) or PubMed Central (PMC) submission identification
numbers must be used for publicly accessible on-line journal
articles. Publicly accessible on-line journal articles or PMC articles/manuscripts
accepted for publication that are directly relevant to the project may be
included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References
Cited section, the Progress Report Publication List section, or the
Biographical Sketch section of the NIH grant application. A URL or PMC
submission identification number citation may be repeated in each of these
sections as appropriate. There is no limit to the number of URLs or PMC
submission identification numbers that can be cited.

Healthy
People 2010:The Public
Health Service (PHS) is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This FOA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.

Authority and
Regulations:
This
program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under the authorization of Sections 301
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards
are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants
Policy Statement.

The PHS strongly
encourages all grant recipients to provide a smoke-free workplace and discourage
the use of all tobacco products. In addition, Public Law 103-227, the
Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some
cases, any portion of a facility) in which regular or routine education,
library, day care, health care, or early childhood development services are
provided to children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.

Loan Repayment
Programs:NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov/.